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Research

Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK

Hind Khalifeh, Emma Molyneaux, Ruth Brauer, Simone Vigod and Louise M Howard
BJGP Open 2019; 3 (4): bjgpopen19X101666. DOI: https://doi.org/10.3399/bjgpopen19X101666
Hind Khalifeh
1 Senior Clinical Researcher and Consultant Perinatal Psychiatrist, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UK
PhD, MRCPsych
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  • For correspondence: hind.khalifeh{at}kcl.ac.uk
Emma Molyneaux
2 Research Associate and Honorary Lecturer, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UK
PhD
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Ruth Brauer
3 Lecturer Pharmacoepidemiology, School of Pharmacy, University College London, London, UK
PhD
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Simone Vigod
4 Associate Professor and Psychiatrist-in-Chief, Women’s College Hospital and Women’s College Research Institute, and Department of Psychiatry, University of Toronto, Toronto, Canada
MD, MSc, FRCPC
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Louise M Howard
5 Professor of Women's Mental Health, Section of Women’s Mental Health, Institute of Psychiatry, Psychology and Neuroscience (IOPPN), King’s College London, London, UK
PhD, FRCPsych
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Article Figures & Data

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    Figure 1. Participant flow diagram
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    Figure 2. Responses to acceptability questionnaire among women who were randomised to receive the patient decision aid (PDA)

Tables

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    Table 1. Sample characteristics
    VariableLevelPDA, n (%)(n = 26)No PDA, n (%)
    (n =25)
    Socio demographic data
    Pregnancy statusPlanning9 (34.6)12 (48.0)
     Pregnant17 (65.4)13 (52.0)
    Mean age, years (SD)31.7 (4.5)34.0 (5.9)
    Marital statusMarried or cohabiting23 (92.0)23 (88.5)
    EducationCollege/university14 (53.8)21 (84.0)
    Family income (≥£40 000)14 (53.8)18 (72.0)
    Obstetric history≥1 prior births16 (61.5)10 (40.0)
    AntidepressantsPrior but no current use12 (46.1)6 (24.0)
     Current use14 (53.9)19 (76.0)
    Psychiatric disorders ( MINI ) a
     Current disordersAny disorder21 (80.8)17 (68.0)
     Major depression15 (57.7)9 (36.0)
     Anxiety20 (76.9)15 (60.0)
    • ↵ aThe abbreviated Mini-International Neuropsychiatric Interview, including modules for mood disorders, anxiety disorders, and substance misuse disorders.

    • PDA = patient decision aid. SD = standard deviation.

    • View popup
    Table 2. Efficacy outcomes: summary scores at baseline and follow-up
    Mean (SD)Difference in means (95% CI)
    Measure (score range)Study groupBaseline scorea t1 scorea t2 scoreb Difference between t1 and baseline scoreDifference between t2 and baseline score
    DCS (0–100)c PDA53.2 (11.5)32.2 (16.4)NA-21.0 (-26.9 to -15.0)NA
    No PDA56.7 (16.6)37.5 (17.0)NA-19.2 (-27.3 to -11.0)NA
    EPDS (0–30)PDA14.5 (7.1)12.8 (6.6)9.0 (4.8)-1.7 (-4.0 to 0.61)-4.9 (-7.9 to -1.9)
    No PDA12.5 (6.2)10.3 (5.9)9.7 (5.5)-2.2 (-4.9 to 0.47)-2.7 (-5.2 to -0.27)
    STAI-state (20–25, 27–80)PDA44.0 (15.2)44.8 (15.5)38.8 (13.7)0.74 (-3.5 to 5.0)-4.2 (-11.8 to 3.5)
    No PDA41.8 (12.8)38.1 (12.3)42.2 (12.6)-3.7 (-9.0 to 1.6)0.35 (-5.6 to 6.3)
    Knowledge questionnaire (0–16)PDA11.3 (2.2)12.5 (1.7)NA1.2 (0.23 to 2.1)NA
    No PDA11.0 (1.5)12.2 (1.9)NA1.1 (0.33 to 1.9)NA
    • a N for baseline and t1 (4-week follow-up) for all outcomes: PDA = 23, no PDA = 23. b N for t2 (long-term follow-up): for EPDS scores PDA = 21, no PDA = 23; for STAI scores PDA = 20, no PDA = 23.

    • CI = confidence intervals. DCS = decisional conflict scale. EPDS = Edinburgh postnatal depression scale. NA = not applicable. PDA = patient decision aid. STAI = state-trait anxiety inventory.

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    Table 3. Efficacy outcomes: analyses of covariance
    ANCOVAa for t1 scoreANCOVAa for t2 score
    n Regression co-efficient Partial eta squared b n Regression co-efficient Partial eta squared
    ( 95% CI ) ( 95% CI ) c ( 95% CI ) ( 95% CI ) b
    DCSPDA23-3.5 (-12.6 to 5.6)0.014 (0.000 to 0.143)—
    No PDA23
    EPDSPDA231.4 (-1.6 to 4.5)0.020 (0.000 to 0.158)21-1.3 (-4.1 to 1.5)0.021 (0.000 to 0.163)
    No PDA2323
    STAI (state)PDA235.1 (1.0 to 11.3)0.062 (0.000 to 0.230)20-3.8 (-11.4 to 3.8)0.025 (0.000 to 0.174)
    No PDA2323
    Knowledge questionnairePDA230.13 (-0.86 to 1.1)0.002 (0.000 to 0.090)–
    No PDA23
    • aANCOVA model of effect of allocation, adjusted for baseline score of the relevant outcome measure. bStandardised effect sizes were estimated using partial eta squared (by convention, values of 0.01, 0.09, and 0.25 indicate small, medium, and large effect sizes respectively). cThe lower limit of the confidence interval was estimated as 0.0 for all analyses.

    • ANCOVA = analysis of covariance. CI = confidence intervals. DCS = decisional conflict scale. EPDS = Edinburgh postnatal depression scale. PDA = patient decision aid. STAI = state-trait anxiety inventory.

Supplementary Data

SUPPLEMENTARY DATA

  • bjgpopen19X101666_Supp.pdf -

    Supplementary material is not copyedited or typeset, and is published as supplied by the author(s). The author(s) retain(s) responsibility for its accuracy.

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Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK
Hind Khalifeh, Emma Molyneaux, Ruth Brauer, Simone Vigod, Louise M Howard
BJGP Open 2019; 3 (4): bjgpopen19X101666. DOI: 10.3399/bjgpopen19X101666

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Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK
Hind Khalifeh, Emma Molyneaux, Ruth Brauer, Simone Vigod, Louise M Howard
BJGP Open 2019; 3 (4): bjgpopen19X101666. DOI: 10.3399/bjgpopen19X101666
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Keywords

  • pregnancy
  • depression
  • antidepressants
  • patient decision aid
  • pilot
  • Randomised Controlled Trial

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